Category: Oversight

A few weeks ago I spent some time chatting with Howard Lovy for an article for the Nanobusiness Commercialization Association.  That interview was posted by Vincent Caprio on his blog a few days ago, and raised a few eyebrows – was I showing signs of becoming a nano-risk skeptic? I hope not, as as I still feel emerging evidence and trends indicate major perceived and real risk-related barriers lie in the path of developing nanoscale science and engineering successfully, if we aren’t smart.  But I have always adhered to the idea that successful and responsible technology development depends on taking an evidence-based approach – even if that evidence is sometimes uncomfortable.  And so these days I sometimes worry that too much is made of artificial constructs surrounding “nanotechnology”, and not enough is made of the underlying science. Reading through Howard’s piece, I felt it was a pretty accurate reflection of our conversation.  There are a couple of places where it possibly indicates less concern on my part than is warranted.  Toward the end of the piece for instance I am quoted as saying “there is no need [for the nanobusiness community] to respond to individual challenges such as this lawsuit against the FDA”, referring to a recent lawsuit by consumer advocates against the U.S. Food and Drug Administration, which claims the FDA is failing to regulate nanomaterials in products. I’m pretty sure I did say something along these lines.  But the context was that lawsuits like these are a relatively widely used mechanism for holding federal agencies to account and prodding them into action.  And while they are often important, the nanobusiness community need to understand this context and be aware of the bigger picture when it comes to responsible and sustainable development. Overall though, the piece captures my increasing

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The European Commission had just adopted a “cross-cutting designation of nanomaterials to be used for all regulatory purposes” (link). The definition builds on a draft definition released last year, but includes a number of substantial changes to this. Here’s the full text of the definition:

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It’s been a while in the making, but with a little under five weeks to go, we have just posted the final program for the 2011 Risk Science Symposium (20-21 Sept).  And even though I say so myself, it’s a doozy! Somehow, we are squeezing 45 invited speakers into the two days, and not any old speakers – the lineup includes John Viera – Ford Motor Co. Director of Sustainability Environment and Safety Engineering; Ray O. Johnson,  Senior Vice President and Chief Technology Officer of Lockheed Martin Corporation; Brian Ivanovic, Senior Vice President of Swiss Re; and Paul Anastas, Assistant Administrator for the Office of Research and Development and Science Advisor to the EPA.  And that’s just for starters.  We also have experts in innovation, policy, communication end engagement, risk, governance and sustainability.  We even have two leading designers from the company IDEO. It’s going to be quite a party! For more information on the speakers, check out the symposium website.  I’ve posted the program below, because I’m so excited about it, but you can also access it here. The symposium is being held in Ann Arbor MI between Sept 20-21.  There are still a few spaces left, but we are nearing capacity – so if you are thinking of coming, it’s worth registering sooner rather than later.

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The materials that most current regulations were designed to handle are pretty simple by today’s standards. Sure they can do some nasty things to the environment or your body if handled inappropriately. And without a doubt some of the risks associated with these “simple” materials are not yet well understood – especially when it comes to long term and trans-generational impacts. Yet it’s hard to escape that reality that researchers are now designing new materials from the ground up that behave in novel ways, that have few analogs in the world of conventional materials, and that exhibit different properties according to the environment they are in. And as they do, it is becoming increasingly apparent that many of the regulations we rely on are ill-equip them to deal with the pending flood of sophisticated materials that is coming our way. The development of relatively simple engineered nanomaterials in recent years has highlighted this disconnect between established regulations and the new demands being placed on them. Fortunately, many of the first nanomaterials to emerge have not presented insurmountable challenges, and regulators have been able to stretch existing regulatory frameworks to cover them (although even this in itself has not been an easy task). But these are just the beginning of a trend in novel materials designed and engineered at the nanoscale that will transcend current regulatory mindsets. So what what are the options here? Before this question can be answered, a clearer understanding of the issues being faced needs to be developed. Some of these are explored by Graeme Hodge, Di Bowman and myself in a commentary in the August 2011 edition of the journal Nature Materials.

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One of the problems with publishing in journals like Nature is that it can get a little pricey for people to read your work if they (or their organization) don’t subscribe.  For instance, if you want to read the commentary I’ve just had published on defining engineered nanomaterials for regulatory purposes, you are facing a hefty $32 fee to push through the paywall.  Now I know that I write interesting stuff.  But I’m not sure it’s that interesting! Which is why I have just posted an earlier draft of the piece over on the Risk Science Blog. This isn’t as focused or specific as the published commentary.  But it gives a rough idea of where I’m coming from. And just because I can, I have also posted link to a later draft, and some notes on the editing process – so that those of you with more time than  sense can study in depth the evolution of the piece from initial scribblings to final product! The early draft can be read here, and the published commentary “Don’t define nanomaterials” (Nature 475, 31 2011) can be accessed here.

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It must be Nanotechnology Regulation week in Washington DC.  Yesterday, two federal agencies and the White House released documents that grapple with the effective regulation of products that depend on engineered nanomaterials. In a joint memorandum, the Office of Science and Technology Policy, the Office of Management and Budget and the Office of the United States Trade Representative laid out Policy Principles for the U.S. Decision Making Concerning Regulations and Oversight of Applications of Nanotechnology and Nanomaterials. On the same day, the US Environmental Protection Agency posted a prepublication notice on Policies Concerning Products Containing Nanoscale Materials. And to cap it all, the US Food and Drug Administration released Draft Guidance for Industry on Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology. A busy week for nanotechnology regulation! White House Memo on Nanotechnology Regulation Policy Principles The White House memorandum is the latest document to come out of the Emerging Technologies Interagency Policy Coordination Committee – ETIPC for short.  In part, it is a response to the 2010 review of the National Nanotechnology Initiative by the President’s Council of Advisors on Science and Technology, and in particular the concern expressed by PCAST that “In the absence of sound science on the safe use of nanomaterials and of technologies and products containing them, the chance of unintentionally harming people and the environment increases.  At the same time, uncertainty and speculation about potential risks threaten to undermine consumer and business confidence.” Correspondingly, this is a memorandum that is heavily focused on science-driven regulation, and the avoidance of knee-jerk responses to speculative concerns. Reading through it, a number of themes emerge, including: Existing regulatory frameworks provide a firm foundation for the oversight of nanomaterials, but there is a need to respond to new scientific evidence on potential risks, and to consider

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Cross-posted from The Risk Science Blog: Back in 2007 the White House Office of Science and Technology Policy (OSTP) issued a set of “Principles for Nanotechnology Environmental, Health and Safety Oversight” (no longer available on the OSTP website it seems, but you can read them in this Nanowerk article). At the time, I was less than enamored with the “don’t mess with business” tone of the principles. So I was particularly interested to read what the White House Emerging Technologies Interagency Policy Coordination Committee (ETIPC) had to say on a very similar issue last month. ETIPC was formed last year, and consists of assistant secretary-level representation from about twenty federal agencies. From the White House blog, the group is …part of an effort to give special attention to technologies so new—such as nanotechnology and synthetic biology—that their policy implications are still being gauged. Created jointly by OSTP, the Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA), and the Office of the United States Trade Representative (USTR), the ETIPC consists of assistant secretary-level representatives from about 20 Federal agencies. The same post goes on to explain that Emerging technologies promise to have significant scientific, economic, and perhaps societal impacts because of their potential to revolutionize fields as varied as materials science, electronics, medicine, communications, agriculture, and energy. Rapid scientific and technological advances in these fields are resulting in a variety of new products and processes with unique and transformational characteristics. But full realization of the economic and public benefits of these applications will require open consideration of policy questions with the full range of stakeholders, including governments, industry, non-governmental organizations, academia, and the public. The first publicly released outcomes of ETIPC were released last month. On March 11 2011, John Holdren (Director of OSTP and Assistant to

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I‘ve just posted a piece over on the Risk Science Blog on regulatory definitions of engineered nanomaterials.  What may come as a surprise to many readers given my comments over the years is the title – “Why we don’t need a regulatory definition for nanomaterials”!  Have I flipped, lost my senses, or what? As you might guess, I still think that engineered nanomaterials present a huge regulatory challenge – both from the perspective of avoiding unnecessary health impacts, and providing manufacturers with clear, rational rules for their safe use.  But I also have this odd idea that regulations should at the minimum be built on evidence if the resulting rules and guidelines are to have any relevance and traction. Sadly, it now looks like we are heading toward a situation where the definitions of nanomaterials underpinning regulations will themselves be based on policy, not science. This scares the life out of me, because it ends up taking evidence off the table when it comes to oversight, and replacing it with assumptions and speculation on what people think is relevant, rather than what actually is – not good for safety, and certainly not good for business. But you can read more about why I’m getting worried about a regulatory definition for nanomaterials over at the Risk Science Blog.

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As anyone who has followed my work over the past few years will know, I have a deep interest in the potential benefits and risks associated with emerging technologies, and in particular whether we can swing the balance towards benefits by thinking more innovatively about risk and how we address it. So it’s not surprising that I’m extremely excited to be chairing this year’s Risk Science Symposium at the University of Michigan, which is all about how we can think differently about human health risk to support sustainable technology innovation. The symposium is shaping up to be a unique event, and one that I hope will expose participants to new ideas as well as energizing them to explore new possibilities as they work toward developing responsible and sustainable products based on technology innovations. Over the next few weeks, we’ll be firming up the program in time for early registration, opening on April 4. Something I’m particularly excited about is that the symposium is turning out to be a great opportunity to explore some different formats for getting people to think differently about common challenges. Rather than use the tried and tested – but often bum-numbingly boring – “talking heads” lecture format, we will be basing most of the proceedings on a series of moderated discussions. These will be designed to engage experts from different perspectives – as well as other participants – in addressing key questions, under the guiding hand of a strong moderator. It’s a format that one colleague described as “symposium speed-dating” – but I think it’s one that will encourage new ideas and insights, and lead to some extremely engaging exchanges. And in case you think that these will go the way of many panel discussions where participants simply use their time (and that of their fellow-speakers

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Here’s an offer I’m sure you won’t be able to resist: The opportunity to read the first and last chapters of the just-published International Handbook on Regulating Nanotechnologies – for free! Due to the farsightedness of my co-editors, the publishers have agreed to let authors post their chapters on their institutional web pages. So if you head over to the Risk Science Blog, you can download the chapter that frames the book, and the one that pulls everything together at the end. Don’t all rush at once! I have to add, this was a master-stroke by Di Bowman in her negotiations with Edward Elgar Publishing- kudos to her!

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Cross-posted from the Risk Science Blog. Take a metaphorical slice through this year’s annual World Economic Forum meeting in Davos, and Global Risk would be writ large through every part of it.  Hot on the heels of the sixth Global Risk report, this year’s meeting saw the launch of the Risk Response Network – a new initiative to facilitate responsive, informed and integrative action on global risks.  And throughout the meeting, sessions and conversations abound that are grappling with understanding and mitigating emerging risks in today’s complex and interconnected world. But important and impressive as this agenda is, I wonder whether there is something missing. I’m approaching risk at Davos this year from three perspectives: exploring the relationship between science, innovation and risk; understanding the impact of emerging risks on public health; and developing technology-enabled approaches to risk mitigation.  The common themes here are science and technology – both as potential drivers of risk, and as sources of possible solutions. From my work in science, technology and public health, it is clear that a deep understanding of the roles of science and technology in addressing risk is critical to building resilient and sustainable responses to global risks.  It is also increasingly clear that integrating this understanding into the process of addressing global risks is vital. Yet this is where the World Economic Forum’s timely thrust to address global risks seems to be somewhat lacking. Science and technology are certainly well-repented on the Davos agenda.  But I get the sense that they are part of the alternative program – “the entertainment” as one colleague described them.  This is probably a little harsh.  But the science and technology sessions do tend to be aimed at wowing delegates, rather than engaging them in exploring integrated solutions to pressing problems – a bit of

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Cross posted from the Risk Science Center Blog: There’s a lot to like in President Obama’s perspective on 21st century regulation. Writing in today’s Wall Street Journal, Obama outlines his thinking behind his new executive order to review and revise a convoluted and potentially disruptive federal regulatory system. But if regulation in the 21st century is to be effective in protecting people and enabling economic growth, it needs to become more sophisticated and innovative, while avoiding the traps of over-simplistic thinking. I’m glad Obama puts a strong emphasis on public health in his op ed. It’s all too easy easy for these conversations to degenerate into regulatory bashing in favor of business freedom – a trap Obama deftly avoids. Yet he is spot on when he calls out the dangers of out-dated and ill-conceived regulations potentially stifling innovation and economic growth – an outcome which ultimately also impacts on public health, albeit in less directly measurable ways. The trick is to find that sweet spot between preventing harm while supporting the economy. As society and the technologies it relies on become ever-more complex, finding this sweet spot is becoming increasingly difficult. New technologies are spawning new products that cause harm in new and sometimes unanticipated ways. An ever more interconnected global society is eroding traditional command-and-control oversight frameworks. And a growing flood of tantalizing yet often incomplete data is creating confusion over what is safe, and what is not. Yet the same changes that are making old-style regulation increasingly difficult are also opening up opportunities for innovation in how we protect people.

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Getting an unbiased perspective on nanotechnology is probably as close to impossible as you can get.  Governments invest in nanotech because they believe in its ability to inspire new research and stimulate economies and social change.  Corporations invest in nanotech because they think it will give them an edge in a hyper-competitive world.  Neither is likely to tell you that nanotechnology is not a good thing, without having very strong reasons to do so.  And NGO’s?  Non Government Organizations come in so many flavors that about the only generality that can be made is that they exist for a purpose – and that purpose is rarely based on an unbiased world-view. One of the more vocal NGO’s in the nanotechnology arena has been the Canadian-based ETC Group.

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Back in the mists of time, I was approached with a crazy proposition – would I help co-edit a book on nanotechnologies regulation!  In a moment of weakness I said yes, and a little more than two and a half years later, the book is finally about to hit the shelves. I actually think the resulting International Handbook on Regulating Nanotechnologies rather a useful, coherent and engaging collection of chapters – my co-editors Di Bowman and Graeme Hodge did a wonderful job encouraging a bunch of top thinkers in the field to write under occasionally whimsical but always relevant titles. To whet your appetite prior to the book’s release sometime in November, here’s a sneak peak at the contents:

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A guest blog by Hilary Sutcliffe, Director of MATTER, a UK think tank which explores how new technologies can work for us all. The other day, I wrote a piece on the implications of synthetic biology where I  suggested that we “need to place discussions on a science basis, and not get over-distracted by ethical hand-wringing.”  It was a bit of a provocative statement – intentionally so – so I was pleased to see Hilary Sutcliffe pick up on it in the comments and push back against the implication that the ethics of synbio might not be as important as some think.  Given the relevance of her comments, I thought they deserved their own guest blog – so here they are – AM. “Ethical hand-wringing”?  Hmm, I don’t think you were quite meaning this as I have interpreted it Andrew, but I have to disagree with your point in your Synthetic Biology Blog on the ethical hand-wringing, I think we should be distracting ourselves quite a lot with Ethical Hand-Wringing while the scientists are getting on with creating their new organisms, especially considering ‘what we understand is secondary to what we can do’, as you said. I was at the Royal Society’s Synthetic Biology Stakeholder meeting which was shown by BBC Newsnight last week, (my Mum and I spotted me fleetingly in the corner!) and this and other recent synbio events gave me many a déjà vu moment – had I accidentally gone to a nano meeting? There are many similarities between the development of genetic modification (GM) and nanotechnologies which can be learned in the development of synthetic biology.  Time is of the essence – GM and nano were pretty much already in the shops when we started to take action, but here perhaps we can get our act

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A bit of a wonky blog I’m afraid, but having seen relatively little on the recently introduced Safe Chemicals Act of 2010 and its relevance to engineered nanomaterials on the web, I thought I would post something short and sweet here. Just over a week ago, Senator Lautenberg introduced a bill in the US Senate aimed at a long-overdue reform of toxic substances regulation in the United States – the Safe Chemicals Act of 2010.  At the same time, Congressmen Rush and Waxman released a discussion draft in the House – The Toxic Chemicals Safety Act of 2010 – covering much of the same ground.  Both documents aim to update substantially the Toxic Substances Control Act, or TSCA – which has been the mainstay of US chemicals regulation since 1976. Both the 169-page Safe Chemicals Act of 2010 and the slightly shorter 119 page long Toxic Chemicals Safety Act of 2010 aim to bring US chemicals safety regulation into the 21st century.  Richard Denison at EDF has already posted a comprehensive overview of proposed changes to the regulation that I would recommend reading if you are into this stuff.  But here, I thought I would highlight what the proposed changes mean for the engineered nanomaterials – a class of substances that have been a bit of a thorn in TSCA’s side for the past few years.

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There’s a bit of a brouhaha over nanotechnology safety brewing over at AOL Online.  A few weeks ago, investigative reporter Andrew Schneider posted a series of articles questioning both the safety of nanotechnology-enabled products entering the market, and the US government’s response to the emerging challenge.  Today, Clayton Teague – Director of the US National Nanotechnology Coordination Office – hit back with an opinion piece calling Schneider to task…

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According to the American Association for the Advancement of Science (AAAS), the White House Office of Science and Technology Policy (OSTP) plans to form a new interagency group on emerging technologies, including nanotechnology and synthetic biology.  The announcement was make by Tom Kalil, deputy director for policy at OSTP, at a government-organized workshop on Risk Management Methods and Ethical, Legal, and Societal Implications of Nanotechnology held last week.  The AAAS policy alert (not available on the web yet available here) noted that the group is intended to provide research funding agencies and regulatory agencies an opportunity to discuss emerging policy issues.

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Back in February of 2009, the UK House of Lords Science and Technology Committee launched an inquiry into the use of nanotechnology in food products and the food industry.  Chaired by Lord Krebs (the son of Hans Adolf Krebs – best known for describing the mechanisms of energy uptake and release in cells), a small group of peers was assembled to address the potential benefits and use of nanotechnology in the food sector, arising health and safety issues, regulation, communication and public engagement.  On January 8 2010, the subcommittee’s much-anticipated report was published.  Concluding with 32 recommendations covering nanotechnology and food commercialization, potential risks, regulation and public communication and engagement, it is perhaps the most comprehensive and authoritative report on the subject to be published to date.

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Andrew Maynard is a Professor of Environmental Health Sciences at the University of Michigan, and directs the U-M Risk Science Center.  His interests focus on effective science communication; the responsible development and use of emerging technologies – most notably nanotechnology and synthetic biology; and how understanding risk can help inform smart decisions.  

As well as writing a regular column for the journal Nature Nanotechnology, Andrew posts regularly on his personal blog "2020 Science", and on Twitter as @2020science.  He also produces short (and hopefully entertaining) educational videos on understanding health risks on the YouTube channel Risk Bites

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